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1.0 - 5.0 years
5 - 8 Lacs
Hyderābād
On-site
Summary of Job To be responsible for pre-formulation and preclinical formulation activities. To be responsible for designing the experiment under supervision and handling associated equipment's and operations along with interpretations. Key Responsibilities 1.Ability to design and execute pre-formulation experiments like solubility, pKa, log P, dissolution, intrinsic dissolution, bulk density, flow indices, solid-state assessment, excipient compatibility etc. 2.Completely conversant with hands on experience and/or interpreting data from pre-formulation studies of a compound including physicochemical, bulk, surface and particle properties. 3.Ability to design and execute preclinical formulations to support lead ID, lead optimization and clinical candidate selection, including but not limited to solution, suspension, powder for constitution, compound filled in capsules and basic tablet ability. 4.Reasonably conversant with hands on experience and/or interpreting data from solid-state equipment's like PXRD, MDSC, TG, DVS and other techniques like Polarizing and Hot-stage Microscopy and other dynamic image analysis techniques, specially during supporting solid form and salt screening. 5.An additional benefit would be to have operational experience of handling Particle size analyzer, HPLC, GC, Dissolution apparatus and Disintegration apparatus. 6.Ability to collate and scientifically present data & observations and provide scientific inputs in discussion with internal or external customers. 7.Proactively maintain the equipment's, facility and supporting systems as per established good lab handling processes, maintain requisite equipment and process SOPs and lean tools 8.Follow good documentation practices and have adequate exposure to record observations in Electronic Lab Notebook (ELN). 9.Proactive in aligning with new technologies and approaches to participate in continuous improvement needs of the business. 10.He/she should have sufficient knowledge chemical safety, comprehensive risk assessment of drug substance and safe handling. Qualification M. Pharma, M.Sc. or M Tech with relevant specialization in Pharmaceutical Sciences Experience 1-5 years Key Competencies (Technical, Functional & Behavioral) Technical & Functional Sound experience of fundamentals of pre-formulation and approaches used for preclinical formulation development of compounds. Basic knowledge on developing clinical formulation would be an added plus. Demonstrated capability in having understanding to design and interpret data from PXRD, modulated DSC, TGA, DVS, Microscopy and working operations of HPLC, GC, FT-IR, NMR, Dissolution, BET and other physical and physicochemical characterization techniques. Hands-on operating would be an added plus. Behavioral Aptitude to learn and excel. Proactive in technical & operational space. Ability to work in cross-functional team environment. Ability to contextualize the observations and attention to detailing. Effective communication skills and absorbing attitude.
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
Sadar, Uttar Pradesh, India
On-site
The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. Show more Show less
Posted 2 months ago
5 years
0 Lacs
Gajraula, Uttar Pradesh, India
On-site
Who We Are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market. How You’ll Spend Your Day Responsible on-Site product transfer & New Product transfer, scale-up, proposals, Capex evaluations & Process Engineering calculations Improvement in the yield, efficiency and cost effectiveness of developed API’s by introducing new Technologies and further development of process fine tuning Extensive experience in API manufacturing with a deep understanding on Scale-up. Troubleshooting the plant related problems, to overcome the process related difficulties for smooth production Contribute novel ideas by way of participation during technical discussion with superiors/ Colleagues Cycle time reduction, Capacity enhancement and making capacity increase proposals with the support of site CFT members/ leads. Ability to manage 4-5 Engineers coaching, career development and build high performing, engaged and effective teams through motivation and inspiration Person will be expected to support chemistry projects to develop the process engineering knowledge and lead the transfer from lab to scale-up lab and further to production scale Experience on handling CDMO products will be an advantage Person will have demonstrated expertise in the scale-up and process understanding of chemical process unit operations in the manufacture of APIs, intermediates and raw materials. Experience in Quality by Design, process safety, technology transfer and commercial production would be advantageous. Person will be responsible to execute trial and validation batches and support in related activities at plant in the time of scale up In-depth, hands-on expertise and up-to-date knowledge of a wide range of chemistry unit operations such as reactions, distillation, separation, filtration and drying. Strong scientific track record, ability to handle several projects in different stages of development at the same time. Person will be responsible to Investigate and troubleshoot in case of issues in scale up/validation and support troubleshooting activities in case of issues in scale up/validation batches Responsible to use process modelling tools like Dyno Chem, VISMIX for reaction, crystallization, filtration, solubility and mixing studies Good knowledge on solvent recovery & recycle by using latest technologies etc Your Experience And Qualifications B. Tech/ M. Tech Chemical (Regular from reputed Institute) 14-16 Years experience & 5 years in people management Excellent communication skills to interact internally with project teams and externally with customers Good project management and supervisory skills. Collaboration and influencing skills to build partnerships with the other disciplines, similar groups, Conscientious with a can-do attitude and thorough attention to detail. A team player & Competent in the use of key process engineering and modelling software packages Equivalent experience in a Process, Synthetic Chemistry or Manufacturing environment. Experience in working to GMP. Experience in the application of Process Safety to the design of chemical processes Reports To Associate Director, MS&T Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Show more Show less
Posted 2 months ago
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